Under federal regulation, sponsors are responsible for ensuring the integrity of safety and efficacy data submitted to the FDA to support their application; they are also responsible for ensuring clinical studies are conducted in accordance with the approved protocol. Audits are an opportunity to assess compliance and not just the quality of data, but the systems that generate that data. This web seminar will highlight the collaborative requirements for facilitating remote auditing and identify key considerations for future studies.

Learning Objectives

Review the purpose and process of audits
Examine critical Clinical Investigator quality systems, subsystems, and processes
Explore study risk assessments to inform the remote auditing plan
Discuss the use of technology to verify objective evidence
Address challenges and potential solutions of virtual audits
Incorporate new FDA guidance and ISO standards to develop a remote audit process

Who Should Attend

Clinical Quality Assurance Auditors
Clinical Quality and Compliance Professionals
Clinical Research Associates
Project Managers
Medical Monitors
Regulatory Affairs Professionals
Clinical Research Coordinators
Clinical Principal Investigators
IRB Administrators and Members

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

Registration Fees

$1,195

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 6 hours (0.6 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-20-091-L04-P. Released: 4/20.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.